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An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis


Phase 2
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

Trial Information

An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis


Inclusion Criteria:



- Subject must have a diagnosis of rheumatoid arthritis based on the American College
of Rheumatology Association

- The subject has active disease at both Screening and Baseline, as defined:

- ≥4 joints tender or painful on motion, AND

- ≥4 joints swollen;

- The subject must have at least one knee, one elbow, one wrist or two
metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver
technique

Exclusion Criteria:

- No arthroscopy should have been performed in the past 3 months in the same joint that
is to be biopsied in this study.

- No intra-articular steroids should have been injected in the joint to be biopsied in
this study in the previous 3 months.

- Subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels <
9.0 gm/dL or hematocrit < 30 % at screening visit or within the 3 months prior to
baseline synovial biopsy.

- An absolute white blood cell (WBC) count of < 3.0 x 109/L (<3000/mm3) or absolute
neutrophil count of <1.2 X 109/L (<1200/mm3) at screening visit or within the 3
months prior to baseline synovial biopsy.

- Thrombocytopenia, as defined by a platelet count <100 x 109/L (< 100,000/mm3) at
screening visit or within the 3 months prior to baseline synovial biopsy.

- Estimated GFR less than 40 ml/min based on Cockcroft Gault calculation .

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28

Outcome Description:

Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.

Outcome Time Frame:

Day -7 (Baseline), Day 28

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3921073

NCT ID:

NCT00976599

Start Date:

November 2009

Completion Date:

July 2011

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteWestminster, Maryland  21157